Seretide Evohaler DC 25/50 GSK treatment of bronchial asthma, chronic pulmonary obstruction (120 doses)

Dosage form Bottle
Specifications Salmeterol, fluticason

Ingredient

Composition information	Content
Salmeterol	50mcg
Fluticason	50mcg

Uses

Indications

Seretide medicine are indicated in the following cases:

Asthma treatment (obstruction of a recovery gas path)

Seretide is indicated in regular treatment of asthma (obstructive gas pathway), including bronchial asthma in adults and children 4 years of age and older. Including:

Patients are not fully controlled with spray corticosteroids and beta -shipping owners, short -effective "when needed" spray.

Patients still have symptoms during treatment with spray corticosteroids.

Patients are being effectively controlled by both beta -owners, prolonged effects and spray corticosteroids.

Seretide is indicated for treatment to maintain obstruction of the gas path and reduce the drama in patients with chronic obstructive pulmonary disease (COPD) and have been shown to reduce the mortality rate for all causes.

Pharmacokic

Seretide contains salmeterol and fluticasone propionate with different acting mechanisms. Salmeterol protects from symptoms, Fluticasone Propionate improves lung function and prevents the disease of the disease. The patient is being treated simultaneously with Beta 2 and Corticosteroids inhaled inhalation may have a convenient regimen with Seretide.

salmeterol

Salmeterol is the owner of the beta 2 sympathetic receptor, which has a selective and prolonged effect (over 12 hours), with the side chain attached to the exterior of the receptor.

Salmeterol's pharmacological characteristics bring more effective protection for bronchospasm of histamine and create longer bronchodilator effects.

Salmeterol is a strong inhibitor and prolonged the release of intermediate substances from moisturizing in the lungs such as histamine, leucotrien and prostaglandin D2.

In humans, Salmeterol inhibits the early and late stages for inhaled allergens, the inhibition of the late period lasts more than 30 hours.

fluticasone propionate

At the recommended dose, Fluticasone Propionate inhaled with anti -inflammatory activity, strong glucocorticoid activity in the lungs, reduces the symptoms and drama of asthma, without any disadvantage, such as when using body corticosteroids.

Usually the daily hormone secretion of the adrenal shell remains in normal range during long -term treatment with Fluticasone Propionate inhaled, even at the highest dose in children and adults. After moving from other inhaled steroids, the daily hormone secretion gradually improves despite using oral steroids in the past and present, this shows that the adrenal gland function returns to normal when treated with Fluticasone Propionate inhaled.

The adrenal gland reserves also maintain at a normal level throughout the long -term treatment process, measured by a normal increase in stimulating test. However, any decrease in the remaining adrenal glands from previous treatment may still persist for a significant time and always need to remember this point.

pharmacokinetics

There is no evidence in animals as well as humans that use the use of salmeterol along with Fluticasone Propionate inhaled, affecting the pharmacokinetics of each component. Therefore, it is possible to consider the pharmacokinetics of each component in a separate way. In a diagonal study with a placebo, to assess the interaction between drugs on 15 healthy subjects, simultaneously use Salmeterol (50 microram twice a day) and CYP3A4 inhibitors are ketoconazole (400 mg oral/day) for 7 days, resulting in significant increase in Salmeterol levels (CMAX increases 1.4 times, AUC increases 15 times).

Do not increase the accumulation of salmeterol when the dose is repeated. There are 3 subjects withdrawal from simultaneous use of salmeterol and ketoconazole due to extending the QTC interval or beating the chest with fast sinus rhythm. Of the remaining 12 subjects, simultaneously using Salmeterol and Ketoconazole does not cause clinical impact on heart rate, blood potassium concentration or QTC.

salmeterol

Salmeterol acts at the lungs, so plasma concentration does not indicate the treatment effect.

In addition, the pharmacokinetic data of Salmeterol is also limited because of the technical difficulties in determining the drug in plasma due to the plasma concentration at the very low inhaled treatment dose (about 200 picograms/ml or lower). When using Salmeterol regularly, XinAfoate may detect hydrogen hydrogen acid in the circulatory system, reaching concentrations in a stable state of about 100 nanogram/ml. These concentrations are 1000 times lower than the concentrations in stable state in toxic studies. No harmful effects when used regularly for a long time (more than 12 months) in patients with respiratory obstruction.

A In vitro study has shown that salmeterol has been converted quite a lot into α-hydroxysalmeterol (aliphatic oxidation process) by cytochrome P450 3A4 (CYP3A4). A study of repeated dose of salmeterol and erythromycin on healthy volunteers has shown that there are no clinical changes on the pharmacological effect at Erythromycin 500 mg, 3 times daily. However, in an interactive study of salmeterol-ketoconazole, there is a significant increase in plasma salmeterol levels.

fluticasone propionate

Fluticasone Propionate's absolute bioavailability for each inhalation tool is estimated from comparison of inhaled and intravenous dynamic data, in healthy adults, absolute estimates for Fluticasone Propionate Accuhaler/Diskus (7.8%), Fluticasone Propionate Diskhaler (9%), Fluticone Proptionate Evohaler (10.9%), Salmeterol - Fluticasone Propionate Evohaler (5.3%) and Salmeterol - Fluticasone Propionate Accuhaler/Diskus (5.5%), in asthma patients or COPD observed the body concentration of Fluticasone Propionate lower inhaled form.

The whole body absorption occurs mainly through the lungs at first quickly and then prolonged. The remaining inhalation dose will be swallowed but only contributes to the absorption of the whole body and the ability to dissolve in water poorly and metabolized before being absorbed to oral use under 1%. When increasing the inhaled dose, the body absorption also increases linear. Fluticasone Propionate has a high level of clearance in blood (1150 ml/min), a large distribution volume at a stable stage (about 300 l) and half a lifetime elimination at the end of about 8 hours. The attachment to plasma protein is relatively high (91%).

Fluticasone propionate excreted very quickly from the circulatory system, mainly converted into carboxylic acid metabolites no longer active, because Cytochrome P450 enzyme CYP3A4.

The renal clearance of Fluticasone Propionate is negligible (less than 0.2%) and less than 5% in the form of metabolites. Should be cautious when used in combination with CYP3A4 inhibitors already know the risk of increasing the body level of Fluticasone Propionate.

Before taking Seretide Evohaler DC 25/50 GSK treatment of bronchial asthma, chronic pulmonary obstruction (120 doses)

How to use

Seretide drugs are used for inhalation.

It is necessary to tell patients that Evohaler DC seretide must be used regularly to achieve optimal benefits, even without symptoms. Patients need to be examined regularly to the seretide content that the patient is taking is always optimal and only changes according to the doctor's advice.

Instructions for use/processing

Check the spray bottle: Before using for the first time, remove the lid of the tube by gently squeeze the sides of the lid, shake the spray bottle well, hold the spray bottle between the thumb and other fingers with the thumb at the bottom of the bottle, under the suck tube and spray into the air until the index counter is sure that the spray bottle works. Shake the spray immediately before spraying. If you do not use a spray bottle for 1 week or longer, remove the lid of the tube, shake the spray bottle carefully and spray one into the air. Each time starting the spray bottle, the number on the counter will decrease by 1.

In some cases, dropping a spray bottle can be a counter.

Use spray bottle

1. Remove the lid of the tube by squeezing the sides of the lid.

2. Check the inner and outside spray, including the tube in the mouth to see if there is any place.

3. Shake the spray bottle carefully to make sure the objects have been removed and the drug ingredients in the spray are mixed.

4. Hold the vertical spray between the thumb and the other fingers, with the position of the thumb at the bottom, the bottom of the suck tube.

5. Breathing out as long as you feel comfortable and then put the tube into your mouth between the teeth and close your lips but do not bite the tube.

6. Immediately after starting inhaled through the mouth, pressing down the top of the spray bottle to release Salmeterol and Fluticasone Propionate while still inhaled and deep.

7. While holding your breath, remove the spray bottle from the mouth and relax your fingers on the top of the spray bottle. Continue to hold your breath until you still feel comfortable.

8. If you continue to spray the second dose, hold the vertical spray and wait about half a minute before repeating the steps from 3 to 7.

9. Then, rinse your mouth with water and spit.

10. Immediately, cover the lid of the spray bottle in the right position. When installed properly, the lid will match the right position. If the lid does not match the right position, rotate the lid in the opposite direction and try again. Do not use too strong force.

Important attention

Do not perform steps 5, 6 and 7 in a hurry. It is important that you start breathing as slow as possible right before operating the spray. Practice using the mirror in the first few times. If you see "dew" emitted from the top of the spray bottle or on both sides of your mouth, you should start again from step 2.

When the 020 counter is, it is advisable to consider a new bottle to replace. When the index counter is, you have to replace the new bottle.

The remaining drug in the bottle may not be enough to provide 1 dose. Never try to change the number on the counter or remove the counter from the metal tank. The counter cannot be reinstalled and is fixed to the flask.

If your doctor offers another user guide, follow it carefully. Tell your doctor if you still have any difficulty.

Dosage

Asthma (obstruction of a recovery gas path)

Should adjust to the lowest dose while maintaining the effective control of symptoms. When the symptom control is maintained at the doses of seretide twice a day, the lowest adjustment to the lowest dose may be Seretide 1 time daily. Patients should be used in Seretide form with Fluticasone Propionate content suitable for the severity of the disease.

If the patient is not fully controlled with inhaled corticosteroid therapy, the replacement treatment with seretide with the doses of corticosteroids is equivalent to treatment that can bring improvement in asthma control. In patients that inhaled corticosteroids are simply controlled, replacement treatment with seretide can reduce corticosteroid dose while maintaining asthma control.

Refer to the "Pharmacological Power" section for more detailed information.

Adults and teenagers aged 12 and older

Two 25 mcg salmeterol sprays and 250 mcg fluticasone propionate, twice daily.

Maximum recommendations for adults and children over 12 years of age is 500/50, 2 times/day.

Chronic obstructive pulmonary disease (COPD)

Adult recommended dose is two sprays 25/250 mcg salmeterol/fluticasone propionate, twice daily. At the dose of 50/500 mcg twice a day, Seretide has been shown to reduce the mortality rate for all causes (see the clinical studies).

Special patient groups

No dose adjustment for elderly patients or patients with renal impairment or liver failure.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Salmeterol overdose is a typical sign of excessive excitation beta2 adrenergic, including tremor, headache, tachycardia, systolic hypertension and hypokalemia. In the overdose of the acute Fluticasone Propionate, it can lead to temporary inhibition of the hill - pituitary - adrenal gland. Often there is no need for emergency treatment due to the adrenal gland function returning to normal for a few days.

If inhaling seretide at a higher dose than the allowed dose for a long time can significantly inhibit the adrenal gland shell. Rarely reports on acute adrenal attacks, mainly occurring in children with higher doses than the allowed dose for a long time (several months or several years), observations that include lower blood glucose accompanied by reduced consciousness and/or convulsions. Situations that may cause acute adrenal attacks include trauma, surgery, infection or any rapid decrease in the inhalation of Fluticasone Propionate.

recommend that patients should not use seretide at higher doses than the allowed dose. Regular checking for treatment and reducing the dose to the lowest dose allowed to maintain the disease effectively is very important.

Treatment

There is no specific treatment for the overdose of Salmeterol and Fluticasone Propionate. If an overdose occurs, patients should be treated with appropriate monitoring if needed.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Seretide drugs , you may experience unwanted effects (ADR).

Infections and parasites

Common: Candida fungal infection mouth and throat, pneumonia (in patients with chronic obstructive pulmonary disease - COPD ), bronchitis.

Rare: esophageal candidiasis.

Uncommon: Hypersensitivity reactions on the skin, shortness of breath.

Endocrine disorders

Rare: Cushing syndrome, phenotype Cushing , adrenal failure, slow growth in children and adolescents, reduce bone mineral density.

Common: Hypotension.

Uncommon: Anxiety, sleep disorders

Very common: headache.

rarely: Run.

Eye disorders

Uncommon: cataracts .

Rare: glaucoma.

Uncommon: beating chest drum, tachycardia, atrial fibrillation, angina.

Rare: Rhythmic includes tachycardia on ventricular and extra mind.

Very common: Nasomitis.

Uncommon: bruises

Common: cramps, joint pain, fractures due to trauma, muscle pain.

Data after circulation

Cardiovascular: arrhythmia (including atrial fibrillation, extra systolic, tachycardia on ventricular), hypertension, tachycardia. Osteoporosis.

Eye: cataracts, glaucoma.

musculoskeletal: back pain, myocarditis Change behavior, including increased activity and stimulation, has been reported very rare and mainly in children. Scales, bruises, blood bruises, sensitive dermatitis, itching.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Seretide medicine contraindicated in the following cases:

Patients with a history of hypersensitivity to any ingredients of the drug.

Initial treatment of asthma or exacerbations of bronchial asthma, COPD when needed actively treatment.

Be cautious when using

deterioration and exacerbations

Seretide Evohaler DC should not be started in patients who are in the period of deteriorating quickly or exacerbations of asthma or COPD is at risk of life -threatening.

Seretide Evohaler DC has not been studied in patients in the exacerbation of asthma or COPD. Start using Evohaler DC seretide in these cases is inappropriate.

Seretide Evohaler DC is not a cutting drug used to reduce acute symptoms, but in this case, a quick and short -acting bronchodilator (e.g. Salbutamol). It is recommended that patients must always have a pills that cut off their side.

Increased use of bronchodilators short -effect to reduce symptoms shows that the control of the disease is deteriorating and the patient should be examined again.

When starting treatment with Evohaler DC Seretide, patients who are taking oral or all the beta receptor -shaped drug users, short -effective with regular doses (e.g. 4 times a day) should be instructed to stop using these drugs regularly.

Use too much Evohaler DC seretide and use simultaneously with the beta receptor owner, other prolonged effects

Seretide Evohaler DC should not be used more than the recommended level, at a higher dose than the recommended dose or simultaneous use with other drugs containing laba, as it can lead to overdose. The clinical impact on the heart and the deaths have been reported related to the overdose of drugs that stimulate inhaled sympathetic. Patients who are using Evohaler DC seretide should not use other drugs containing laba (for example: salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.

The on -site effect of inhaled corticosteroids

In clinical trials, the development of infection in the mouth and throat by Candida Albicans occurred in patients treated with Evohaler DC seretide. When there is such an infection, it is necessary to be treated with anti -fungal therapy (oral) or appropriate local treatment while treatment with Evohaler DC seretide is still continuing, but sometimes treatment with Evohaler DC Seretide may be stopped. Advice for patients with mouth rinse with water and spit out after inhalation can help reduce the risk of candidiasis in the pharyngeal.

pneumonia

There has been an increase in pneumonia reports in studies in COPD patients using seretide (see unwanted effects). Doctors should be wary of the likelihood of pneumonia in COPD patients because of the clinical characteristics of pneumonia and the play of COPD often overlap.

Conversion from body corticosteroid therapy to Seretide

Because the ability to decline in adrenal gland response can occur, patients who move from oral steroids to Fluticasone Propionate inhaled should be treated carefully and regularly monitor the adrenal function regularly.

After starting to use Fluticasone Propionate inhaled, systemic steroids should be gradually reduced and stop and encourage patients to carry a warning card about steroids indicating that patients may need additional steroid treatment during stress.

Inhibit the adrenal glands and cushing status due to drugs

Fluticasone Propionate, a component of Evohaler DC seretide, will help control better asthma symptoms while less inhibiting the hypothalamus - pituitary - adrenal glands than the oral Prednisone at an equivalent dose level. Because Fluticasone Propionate is absorbed into the cycle and can cause a systemic effect at a higher doses, the advantage of Seretide Evohaler DC in reducing the dysfunction of the hypothalamus dysfunction - pituitary gland - adrenal gland can only be achieved when the dose does not exceed the recommended dose and each patient is adjusted to the lowest dose to the lowest dose.

The relationship between Fluticasone Propionate concentration in plasma and inhibiting cortisol production has been observed after 4 weeks of treatment with Fluticasone Propionate inhalation. Because each individual has a sensitive level for the effect of the drug on different cortisol production, the doctor should consider this information when prescribing Evohaler DC seretide.

Because of the possibility of inhaled corticosteroids significantly absorbed into the circulatory round in sensitive patients, patients treated with Evohaler DC seretide should be carefully monitored any body effects of corticosteroids. These patients should be paid special attention after surgery or during the stress period because the adrenal response may be incomplete.

The systemic effects of corticosteroids such as cushing due to drugs and adrenal inhibitors (including acute adrenal failure) may appear in a few patients sensitive to these effects. If such effects occur, Evohaler DC seretide should be slowly reduced the dose, in accordance with the accepted process of reducing the dose of systemic corticosteroids, and other treatments to control asthma symptoms should be considered.

Interaction with strong Cytochrome P450 3A4 inhibitors

In a drug interactive study when used with Ketoconazole, observing an increase in exposure to Seretide. This can lead to the extension of QTC. Be careful when combining strong CYP 3A4 inhibitors (for example, as ketoconazole) with seretide (see interaction and pharmacokinetics).

paradoxical bronchospasm and upper respiratory symptoms

Like other inhalers, paradoxical bronchospasm can occur with increased wheezing symptoms immediately after taking the drug. In this case, patients should be treated immediately with a quick and short -acting bronchodilator. Should stop using Evohaler DC Seretide immediately, patients need to be assessed and replaced if necessary (see unwanted effects). The upper respiratory symptoms of spasms, irritation, or laryngeal edema, such as wheezing and suffocation, have been reported in patients using Evohaler DC seretide.

Instant hypersensitivity reactions

Instant hypersensitivity reactions (for example: urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylactic reaction, may occur after using Evohaler DC seretide.

Effects on cardiovascular and central nervous system

Beta-adrenergic stimuli can cause seizures, angina, hypertension or lower blood pressure, fast heart rate with a frequency of up to 200 beats/min, arrhythmia, restlessness, headache, tremor, chest drum, nausea, dizziness, fatigue, discomfort and insomnia (see overdose). Therefore, Seretide Evohaler DC, like all products containing other sympathetic amines, should be used cautiously in patients with cardiovascular disorders, especially coronary artery failure, arrhythmia, and hypertension.

Salmeterol, a component of Evohaler DC seretide, can cause significant clinical significance on some cardiovascular patients expressed by heart rate, blood pressure, and/or other symptoms. Although such effects are not common after using salmeterol at the recommended dose, if they occur, may need to stop using the drug.

Bone mineral density (Bone Mineral Density-BMD)

Reducing bone density (BMD) has been observed in patients using long -term drugs containing inhaled corticosteroids. Patients with high risk factors for reducing bone mineral density such as long -term immobility, family history of osteoporosis, menopause, use of tobacco, high age, poor nutrition, or regular use of drugs can reduce bone mass (for example: oral corticosteroid convulsions) should be monitored and treated appropriately.

Because COPD patients often have many risks to reduce BMD, BMD evaluation is recommended before starting using seretide and periodically. If the BMD is significantly reduced, the Evohaler DC Seretide is still an important drug to treat the patient's COPD, using the drug to treat or prevent osteoporosis carefully considered.

Effects on growth

Corticosteroid inhaled inhalation may cause a reduction in children's growth when used for children. It is necessary to monitor the growth of children using Evohaler DC seretide regularly (for example: through height measurement). To minimize the systemic effects of corticosteroids inhaled in the mouth, including Evohaler DC seretide, need to adjust the dose of each patient to the lowest dose effectively control symptoms.

Obmtrophy and cataracts

Glaoma glaucoma (glaucoma), internal hypertension (Increased intrained intransure), and cataracts have been reported in asthma and COPD patients after prolonged inhaled corticosteroids, including fluticasone propionate, a component of Evohaler DC seretide. Therefore, it is necessary to closely monitor patients with vision changes or a history of internal pressure increased, glaucoma, cataract, and central retinal disease (Central Serous Choriorinopathy - CSCR).

other warnings and caution

Hen control becomes sudden and progressive to be life -threatening and patients need to be examined again. Corticosteroid dose should be considered. Patients should also be examined again when the seretide dose is using asthma.

Patients with asthma should not stop using seretide suddenly because it can lead to a drama, so the dose should be slowly reduced under the supervision of the doctor. For COPD patients, the stop treatment may cause loss of symptoms and should be monitored by a doctor.

Should use seretide caution in patients with armor poisoning.

A decrease in transient serum potassium can occur with all sympathetic stimulants at a higher dose than the treatment dose. Therefore, careful use of seretide in patients can easily lower serum potassium.

There are very few reports on glycemic increase and need to be cautious when prescribing patients with a history of diabetes.

There have been reports on unwanted pharmacological effects when treated with Beta2, such as tremor, a thrill of chest drum and headache, but tend to be transient and decreased when treated regularly.

The ability to drive and operate machinery

There is no separate research on the effect of the drug on driving and operating machinery, in addition to the pharmacological characteristics of both active ingredients, there is no impact on the above activities. However, drivers and operating machinery should pay attention to the unwanted effects of the drug including headache, cramps, joint pain, fractures due to trauma, muscle pain.

In addition, the drug may also have unwanted effects such as tremor, anxiety, sleep disorders, shortness of breath, face and mouth edema - pharyngeal, bronchospasm, bronchial bronchial, tachycardia, atrial fibrillation and angina.

Pregnancy

data in pregnant women is limited. Seretide should only be considered for pregnant women if the benefit for mothers is greater than any risk that may occur for the fetus.

Breastfeeding period

should only consider using the drug while breastfeeding if the benefit gives the mother superior to any risks that can be given to the child.

Drug interaction

should avoid using both selective and non -selective beta inhibitors unless there is a mandatory reason.

Under normal conditions, due to the initial metabolism and high body clearance through cytochrome P450 3A4 intermediaries in the intestine and liver, the concentration of fluticasone propionate in plasma is low after the inhalation. Therefore, it is less likely to have clinical drug interactions via Fluticasone Propionate.

A study of drug interactions in healthy people shows that Ritonavir (strong inhibitor of Cytochrome P450 3A4) can cause increased plasma fluticasone propionate levels, resulting in a significant reduction in serum cortisol levels. During the use of the drug after the drug was circulated, there was a report on clinical drug interaction in patients using fluticasone propionate inhaled through the nose or mouth and ritonavir leading to the systemic effect of corticosteroids including cushing syndrome and adrenal inhibition. Therefore, avoid simultaneous use of fluticasone propionate and ritonavir unless the benefits are superior to the risk of corticosteroid side effects.

Studies show that other Cytochrome P450 3A4 inhibitors increase omromycin negligible and slightly increased (ketoconazole) fluticasone propionate levels body without significantly reducing the concentration of cortisol in serum. However, be cautious when using a combination of strong Cytochrome P450 3A4 inhibitors (such as ketoconazole) due to the ability to increase the level of fluticasone propionate.

Concomitance Ketoconazole and Salmeterol increases significantly in plasma salmeterol levels (CMAX increases by 1.4 times and AUC increases by 15 times) and this can cause QTC.

Seretide Evohaler DC should be used very carefully in patients who are being treated with imaos or 3 -round antidepressants, or have just stopped using within 2 weeks of the above drugs, because of the impact of salmeterol, a component of Evohaler DC seretide, on the blood vessel system can increase sharply by these factors.

Change ECG and/or reduce blood potassium due to the use of potassium diuretics (such as diuretics or thiazide) can become worse due to beta -shunned drugs, such as salmeterol, a component of Evohaler DC seretide, especially when used exceeding the recommended doses of Beta fortunes. Although the clinical significance of these impacts is not known, it should be cautious when using Evohaler DC seretide simultaneously with potassium diuretics.

Storage

Close the lid of the tube definitely and push in the right position.

Seretide Evohaler DC should be stored no more than 30 ° C. Avoid freezing and direct sunlight.

Like most of the inhalers in other pressure tanks, the treatment effect of the drug may be reduced when the bottle is cold. Do not puncture, break or burn the jar even when the vessel is empty.

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